Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess - Proposal for a Multicenter Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 368
- 试验地点
- 3
研究概览
简要总结
Peritonsillar abscess (PTA) is a collection of pus between the palatine tonsil and the constrictor muscle. PTA is detected by recognizing characteristics during clinical examination: redness, pain, malaise, trismus, and unilateral peritonsillar swelling. Clinical assessment, including inspection and palpation, is the traditional diagnostic method for patients suspected of having PTA. If PTA is suspected, aspiration with a large-gauge needle or incision is performed to drain the abscess . It can be challenging to distinguish PTA and peritonsillar cellulitis (PTC) based on clinical examination alone. Due to the increased availability of point-of-care ultrasound, it is a part of the diagnostic workup of PTA. Several studies have shown that transoral US can improve the diagnostic accuracy of patients with a suspected PTA. However, no large multicenter study has evaluated whether one of these methods is superior to the other. It is therefore very clinician-dependent whether the patient will have a transoral US performed or not. The investigators hypothesize that transoral US will increase the diagnostic accuracy of PTA compared to solely clinical examination, which is a visual and palpatory assessment. This will result in fewer unnecessary aspiration attempts and overlooked PTAs. Additionally, the investigators wish to investigate the number of aspirations of transoral US-guided needle aspirations compared to aspirations without ultrasound.
Methods This is a cluster randomized study. Patients with suspected PTA will be randomized 1:1 to groups A and B. The cluster randomization will happen weekly using an online randomization tool.
Participants are patients refeered to the outpatient clinic on suspicion of a peritonsillar absces.
The primary outcome is the diagnostic accuracy
The investigators aim to determine whether transoral US is a standard part of the clinical examination by comparing clinical examinations with and without US.
详细描述
Introduction Peritonsillar abscess (PTA) is a painful infection with potentially severe complications. The incidence is estimated at 37 per 100,000 annually, with a peak in teenage life and decline until old age, making it the most common deep neck infection.
Peritonsillar cellulitis (PTC) is an inflammation of the peritonsillar area due to infection but without pus formation. To distinguish PTA, PTC, and acute tonsillitis based on symptoms and clinical presentations alone can be difficult, as they resemble. This includes fever, sore throat, trismus, dysphagia, peritonsillar swelling, and deviation of the uvula away from the affected area. Distinguishing PTA, PTC, and acute tonsillitis is important, as the treatment and diagnostic approach differ. The current treatment for suspected PTA is aspiration, incision, or quinsy tonsillectomy combined with antibiotics. In contrast, the only treatment for PTC and acute tonsillitis is antibiotics.
Computed tomography (CT) scan is a well-known image modality for distinguishing PTA, PTC, and acute tonsillitis. However, this imaging modality is expensive, exposes patients to radiation, and delays treatment. Ultrasound is a radiation-free, cost-effective, and hands-on modality. Benefits that CT scans lack. The conditions for ultrasound usage in the ENT outpatient clinic are good, and ENT physicians commonly use it in Denmark. Ultrasound to diagnose a suspected PTA can be performed cervically and transorally. Both methods are considered valuable tools in PTA diagnostics. In a 2023 meta-analysis, a study describe the use of transoral ultrasound to distinguish PTA and PTC with a transoral 91% specificity and 75% sensitivity. So far, no studies investigating transoral ultrasound of PTA have included more than 46 patients; one study compared transoral ultrasound with a relevant CT scan, and only two randomized controlled trials (RCT) compared transoral ultrasound with clinical evaluation.
Smaller transoral ultrasound probes provide direct access to the peritonsillar region through the oral cavity, yielding more distinct ultrasound imaging than cervical ultrasound. It is also possible to do transorally ultrasound-guided aspiration in contrast to the cervical ultrasound.
Methods This is a prospective multicenter cluster randomized trial reported according to the SPIRIT guidelines. Cluster randomization is relevant in this setting, as this study is a low-intervention study; it does not involve any interventions beyond transoral ultrasound, which is equally effective for diagnosing a PTA. Informed consent following the claims §§ 3-5 is irrelevant, as both randomisations are a standard way to diagnose a PTA, the disease is an acute condition, and a 24-hour consideration period is impossible. This study investigates whether transoral ultrasound improves diagnostic accuracy and outcomes in patients with suspected PTA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred to the ENT outpatient clinic with a suspected PTA.
- •18 years of age or older.
排除标准
- •Unable to understand the verbal information, participating in research.
- •Prior surgical interventions (needle aspiration, surgery, incision) during the course of the disease.
- •Compromised airways, needing acute airway management.
研究组 & 干预措施
Investigation without ultrasound. Control group.
No ultrasound
Standard diagnostic workup and treatment All patients with suspected PTA receive a clinical head and neck examination, including visual inspection of the mouth and throat, and a flexible fiberoptic laryngoscopy (to assess the extent of the abscess in the pharynx and possible edema). If a PTA is suspected, needle aspiration will be performed, followed by relevant antibiotics. Before transoral ultrasound and needle aspiration, a spray of topical anesthetic (lidocaine spray 10 mg/dose) will be applied. In some cases, for example, if the patient has previously had a PTA, an acute tonsillectomy is offered. If the examination does not reveal a PTA, the patients will receive conservative treatment with relevant antibiotics. The patients will be scheduled for a 24-48-hour follow-up if the physician deems it necessary.
干预措施: Transoral Ultrasound (Device)
Intervention/clinical investigation with ultrasound
Intervention group
Transoral ultrasound A head and neck surgeon, often an ENT resident, will perform the transoral ultrasound. A hockey stick transducer is used for transoral ultrasound diagnostics. The procedure is performed by placing the transducer in a disposable glove filled with ultrasound gel. Transoral ultrasound is initiated by positioning the transducer on the palatoglossal arch and a cranial to caudal sweep of the tonsil.The affected tonsil and its surroundings are scanned. An abscess will appear as a hypoechoic area between the tonsil and the constrictor muscle or inside the tonsil. There will be no flow in an abscess when Color Doppler is applied. The unaffected tonsil and the surrounding area can be scanned as a reference.
If randomization is with transoral ultrasound, the aspiration attempts can be performed ultrasound-guided.
干预措施: Transoral Ultrasound (Device)
研究者
Tobias Todsen
MD, PhD, Professor
Rigshospitalet, Denmark